An Indian Council of Medical Research (ICMR) study revealed that the use of the convalescent plasma (CP) therapy in COVID-19 patients does not help in reducing the risk of mortality with moderate or severe symptoms.
This evolution has given rise to the possibility of disrupting the existing programmes of developing convalescent plasma therapy in our country.
The top medical body funded this multi-centre study to investigate and find out the effectiveness and potency of the CP therapy in treating COVID-19 patients and the research agency came up with the revelations after conducting a survey in more than 39 hospitals all over India.
The study has been titled as ‘Convalescent plasma in the management of moderate COVID-19 in India: An open-label parallel-arm phase II multicentre randomized controlled trial (Placid Trial).’ It was conducted from April 22 to July 14 and was registered with the Clinical Trial Registry of India (CTRI).
It also said that the therapy was not effective in preventing the contagious infection from spreading further. On September 8, 2020, the results of the trial were released in pre-print server MedRxiv which said, ‘CP was not associated with a reduction in mortality or progression to severe COVID-19.’ However, the study will be peer-reviewed soon for better clarity.
India had a lot of expectations from the plasma therapy and has made a lot of efforts in promoting it with hospitals and states coming up with plasma banks as well as they vouched for its efficiency. Doctors in Maharashtra, Haryana and Delhi were even prescribing the therapy to patients with mild symptoms.
The study conducted involved around 1,210 COVID-19 patients with mild symptoms who were screened at 39 hospitals across India. Out of these, 10 were private hospitals while 29 were government centres, across 14 states and Union Territories that represented around 25 cities.
However, the medical body conducted the study on random 464 patients who were admitted in hospitals with moderate COVID-19 symptoms. Of these, 235 patients were placed in the intervention arm or CP and 229 other participants were placed in the control arm or BSC arm. The study stated that the subjects were randomly put into the respective arms. 200 ml CP with a double dose was injected 24 hours apart in the intervention arm.
Most of the participants were male with an account of 94.3% with an average age of 34.3 (9.3) year. The duration of the infection was six days and around 94.2% of the patients had moderate symptoms.
‘Composite primary outcome was achieved in 44 (18.7 per cent) participants in the intervention arm and 41 (17.9 per cent) in the control arm. Mortality was documented in 34 (13.6 per cent) and 31 (14.6 per cent) participants in intervention and control arm, respectively,’ the ICMR study said.
‘Convalescent Plasma was not associated with a reduction in mortality or progression to severe COVID-19. This trial has high generalisability and approximates real-life setting of convalescent plasma therapy in settings with limited laboratory capacity. A prior measurement of neutralizing antibody titres in donors and participants may further clarify the role of CP in the management of COVID-19,’ the study added.
Previously, the study conducted by the ICMR in April also did not provide satisfactory results but still private hospitals are prescribing it. ‘Private players are trying to say it works and they are making money whereby they are putting undue pressure to opt for this expensive therapy,’ The Economic Times quoted an epidemiologist as saying.
Also Read: Uttar Pradesh: Nine COVID Centres In Agra Fail Fire Safety Test
